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Rituximab + GM-CSF in Patients With Follicular B-Cell Lymphoma

3. november 2015 opdateret af: M.D. Anderson Cancer Center

Rituximab (IDEC-C2B8) Plus GM-CSF in Patients With Follicular B-Cell Lymphoma

The goal of this clinical research study is to see if using the drugs Rituximab (IDEC-C2B8) and Granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leukine) together is better than using rituximab alone to treat follicular B-cell lymphomas. The safety of this treatment will also be studied.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Rituximab seeks out and helps destroy cancer cells. GM-CSF stimulates the body to produce white blood cells.

Before treatment starts, patients will have a complete exam, including blood and urine tests. A chest x-ray and a CT scan or MRI scan of the abdomen and pelvis will be done to measure tumors. Bone marrow and lymph node samples will be taken.

Women who are able to have children must have a negative blood pregnancy test.

Patients in this study will receive both rituximab and GM-CSF. The combined treatment will last 8 weeks.

Rituximab will be given through a needle in a vein over 3-6 hours once a week. GM-CSF will be given through a needle under the skin 3 times a week. The first of these 3 doses will be usually given 1 hour before the rituximab dose. In selected cases, GM-CSF will start 1 week before or 1 day after the rituximab.

Patients may also receive the drugs acetaminophen (Tylenol) and diphenhydramine hydrochloride (Benadryl) 30-60 minutes before each dose of rituximab. This will be done to ease side effects. Patients may need to stay in the clinic for up to 2 hours after rituximab is given.

If the combined Rituximab and GM-CSF treatment causes severe side effects, the treatment may be stopped.

During the study, blood tests will be done before each rituximab treatment and after the first and fourth rituximab treatments. About 2 to 6 teaspoons of blood will be drawn for each test. A physical exam and a urine test will be done before the fourth rituximab treatment.

After all treatment is done, patients will have a complete exam, including blood tests once a week for 4 weeks and then at 2, 3, 6, 9, 12, 18, and 24 months. A CT scan or MRI scan of the abdomen and pelvis will also be done at 2, 3, 6, 9, 12, 18, and 24 months. Bone marrow samples will be taken at 2, 3, and 12 months. Some patients may also have bone marrow samples taken once a year after that. A large needle will be used to take the bone marrow samples.

This is an investigational study. GM-CSF and rituximab are approved for commercial use by FDA. As many as 40 patients will take part in the study. All will be treated as outpatients. The study will take place only at the University of Texas (UT) MD Anderson Cancer Center (MDACC).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

42

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • University of Texas MD Anderson Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Histologically confirmed follicular B-cell lymphoma. This can include relapsed patients, who have had no prior rituximab therapy, or previously untreated patients. Previously untreated patients should be made aware of higher priority protocols such as combination chemo-immunotherapy protocols, but if they decline that, they can be entered on this protocol.
  2. Males or females, 18 years or older; expected survival of =/> 4 months; performance status of 0, 1 or 2.
  3. Demonstrable monoclonal cluster of differentiation antigen 20 (CD20)-positive B-cell population.
  4. Acceptable hematologic status including:

i. hemoglobin (Hgb) =/> 8.0 gm/dL

ii. White blood count (WBC) =/> 3.0 x 10^3/mm^3(x 10^9/L)

iii. Absolute granulocyte count =/> 1.5 x 10^3/mm^3

iv. Platelet count =/>75 x 10^3/mm^3

e. Adequate renal function (serum creatinine ≤ 2mg/dl)

Exclusion Criteria:

  1. presence of Central Nervous System (CNS) Lymphoma
  2. chronic lymphocytic leukemia (CLL)
  3. small lymphocytic lymphoma
  4. therapy in prior 3 weeks (6 weeks for nitrosourea; 6 months for Bone Marrow Transplantation (BMT))
  5. patients who received prior rituximab or other anti-CD20 therapy
  6. serious non-malignant disease, or other malignancy
  7. active infection
  8. history of HIV infection

i pregnancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Rituximab + GM-CSF
All patients receive one (1) course of therapy consisting of four (4) doses of rituximab, a single dose 375 mg/m^2 administered once weekly for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly (tiw) for 8 weeks, starting 1 hour before the first dose of rituximab. In selected cases, the GM-CSF starts 1 week before, or 1 day after, the first rituximab dose.
Medicin: Rituximab
375 mg/m^2 by vein once a week for 4 weeks on Days 1, 8, 15, 22.
Andre navne:
  • Rituxan
Medicin: GM-CSF
250 mcg subcutaneously 3 times a week for 8 weeks.
Andre navne:
  • Leukin
  • Sagramostim

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Response Rate of Rituximab plus GM-CSF of repeat doses (once weekly times four)
Tidsramme: 1 month
Response Rate is the number of participants with response compared to total. Response definitions: Complete response (CR) defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays. Complete response "unconfirmed" (CRu) defined on the basis of minimal residual abnormalities on x-ray such as a residual mass <25% of original measurement with no palpable disease on physical examination. Partial response (PR) defined as 50-75% reduction in the product of palpable tumor diameters of in the tumor volume measurements by radiologic criteria or any palpable disease such as peripheral node(s) > 1 cm in diameter or palpable abdominal mass with histological evidence of lymphoma cells. Minor response or failure includes <50% tumor shrinkage, or > 50% but with tumor regrowth between courses.
1 month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

M.D. Anderson Cancer Center

Samarbejdspartnere

Genentech, Inc.

Efterforskere

  • Ledende efterforsker: Felipe Samaniego, MD, MPH, BS, M.D. Anderson Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 1999

Primær færdiggørelse (Faktiske)

1. december 2006

Studieafslutning (Faktiske)

1. september 2013

Datoer for studieregistrering

Først indsendt

6. september 2013

Først indsendt, der opfyldte QC-kriterier

6. september 2013

Først opslået (Skøn)

11. september 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. november 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2015

Sidst verificeret

1. november 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DM98-304

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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